"65219-160-10" National Drug Code (NDC)

Busulfan 8 CARTON in 1 CARTON (65219-160-10) > 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-160-01) > 10 mL in 1 VIAL, SINGLE-DOSE
(Fresenius Kabi USA, LLC)

NDC Code65219-160-10
Package Description8 CARTON in 1 CARTON (65219-160-10) > 1 VIAL, SINGLE-DOSE in 1 CARTON (65219-160-01) > 10 mL in 1 VIAL, SINGLE-DOSE
Product NDC65219-160
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameBusulfan
Non-Proprietary NameBusulfan
Dosage FormINJECTION
UsageINTRAVENOUS
Start Marketing Date20191111
Marketing Category NameANDA
Application NumberANDA210931
ManufacturerFresenius Kabi USA, LLC
Substance NameBUSULFAN
Strength6
Strength Unitmg/mL
Pharmacy ClassesAlkylating Activity [MoA], Alkylating Drug [EPC]

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